Tuesday, December 30, 2014

http://www.masscfids.org/resource-library/15-conference-reports/444-dr-byron-hyde-2012-fall-lecture-summary#LAEpidemic
1934 Los Angeles ME epidemic:
Dr. Hyde had the opportunity to examine two physicians who had become ill during the 1934 polio epidemic outbreak at the Los Angeles (LA) County Hospital. According to Dr. Hyde’s slide, 198 healthcare workers, who were immunized with sera from recovering patients, fell ill with ME, but not polio.
He believes in this case that the combination of an immunization and viral infection triggered their ME. The two doctors sued the hospital and the city of LA and received about 2 million dollars each. Dr. Hyde’s hypothesis is that this was a wake-up call for insurance companies to dismiss the illness and from then onward, anything resembling ME was mocked. There were times then, and even now, where ME patients were put into psychiatric hospitals and labeled as crazy (plus they were given drugs that made them sick). So, when CFS came along, it seemed to follow the same pattern. Same illness, different name, same outcome.

Postexertional neuroimmune exhaustion (PENE pen’-e): Compulsory
This cardinal feature is a pathological inability to produce sufficient energy on demand with prominent symptoms primarily in the neuroimmune regions. Characteristics are as follows:
1. Marked, rapid physical and/or cognitive fatigability in response to exertion, which may be minimal such as activities of daily living or simple mental tasks, can be debilitating and cause a relapse.
2. Postexertional symptom exacerbation:e.g.acute flu-like symptoms, pain and worsening of other symptoms.
3. Postexertional exhaustion may occur immediately after activity or be delayed by hours or days.
4. Recovery period is prolonged, usually taking 24 h or longer. A relapse can last days, weeks or longer.
5. Low threshold of physical and mental fatigability (lack of stamina) results in a substantial reduction in pre-illness activity level.

PENE is also objectively verifiable and measurable using the 2-day cardiopulmonary exercise test (CPET):

"A test-retest cardiopulmonary exercise study revealed a drop of 22% in peak VO2 and 27% in VO2 at AT [anaerobic threshold] on the second day evaluation. [39] Both submaximal and self-paced exercise resulted in PENE. [40] These impairments and the loss of invigorating effects distinguish ME from depression." [IC Primer, page 2]

The cardinal feature of CFS, on the other hand, is subjective, self-reported, unexplained fatigue that can only be assessed using variable responses to questionnaires.

Sunday, December 28, 2014

A psychiatrist has been charged with 52 counts of health care billing fraud mainly involving nursing home residents or patients who died.
Dr. Robert Hadley Gross of San Angelo faced a court appearance Thursday in Abilene.
Federal prosecutors in Lubbock say Gross was arrested Wednesday at his office on charges that he defrauded Medicare and Medicaid of more than $1.7 million.
http://m.washingtonexaminer.com/texas-psychiatrist-charged-with-52-counts-of-fraud/article/feed/2173684

Friday, December 26, 2014

A BEDBOUND woman from Bookham whose illness inspired her to start a charity bringing joy to hundreds of sick children has received an award from the Prime Minister on her 30th birthday.
Vikki George was named a Point of Light by David Cameron on Sunday in recognition of her charity Post Pals, which endeavours to cheer up seriously ill children with cards, letters and gifts.
The 30-year-old's achievements are all the more poignant given her diagnosis with severe myalgic encephalomyelitis, commonly known as ME, at the age of 17.
The condition has, over the past five years, affected her ability to walk, talk or even lift her head.
Read more: http://www.dorkingandleatherheadadvertiser.co.uk/Bedbound-woman-Bookham-honoured-Prime-Minister/story-25762525-detail/story.html#ixzz3N0usbYVW
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Friday, December 19, 2014

"38 The Oxford criteria (published in the Journal of the Royal
39 Society of Medicine in February 1991) are flawed and include people with other conditions,
40 confounding the ability to interpret the science."
"378 Specifically, continuing to use the Oxford definition may impair progress and cause
379 harm. Thus, for needed progress to occur we recommend (1) that the Oxford definition be
380 retired"
SOURCE: https://prevention.nih.gov/docs/programs/mecfs/ODP-MECFS-DraftReport.pdf

PHILADELPHIA, Dec. 9, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced today that it has received a new research report (dated December 5, 2014) from researchers at Howard University, Washington DC. The report describes a study in which Ampligen® (Poly I : Poly C12U) strongly inhibited the Ebola minigenome in the human embryonic kidney cell system. The Ebola minigenome replication system was recently described by the researchers in the Journal of Biological Chemistry (2014) (Role of Protein Phosphatase 1 in Dephosphorylation of Ebola Virus VP30 Protein and Its Targeting for the Inhibition of Viral Transcription; Ilinykh et al. 289(33):22723-22738). In the minigenome replication system, certain genetic information for viral proteins has been deleted from the genomic array to permit safer and more efficient laboratory manipulations.

Most importantly, the current Howard University results taken in conjunction with previous data on anti-Ebola actions of Ampligen® reported by other US and European collaborators, indicate that the antiviral molecular actions of Ampligen® may be triggered at levels reached by the common human treatment regimens of Ampligen which have historically been used in clinical studies in a variety of other human diseases. These regimens of Ampligen®, an experimental therapeutic, have been deployed to date over 100,000 times in over 1,000 patients. Today's report also extends the histologic range of human cell types in which Ampligen® has demonstrated strong bioactivity against Ebola at low drug concentrations. Ebola is known to multiply in many different parts of the body destroying multiple types of cells, leading to high morbidity and mortality rates.

Recent articles in New England Journal of Medicine (November 27, 2014) emphasize that in subsets of severely ill EVD patients, parenteral therapy, rather than oral based treatments, will be necessary. Ampligen®, an experimental therapeutic, may be able to meet this requirement.

Previously, the Department of Life and Environmental Sciences, University of Cagliari, Italy reported that Ampligen® can successfully bind to the lethal EVD viral protein designated VP35. VP35 protein normally inactivates a patient's immune/antiviral system by binding to viral dsRNA thereby sequestering a critical antiviral/immune activator of the body which leads to high morbidity and death rates. The experimental outcome achieved by the Cagliari University is consistent with recent predictions published in the Nature group Emerging Microbes and Infections (3, e77; doi:10.1038/emi.2014.77; published online 29 October 2014) by affiliates of Hemispherx.

Another recent US government research report observed that the inhibiting concentration (EC50) of Ampligen® for Ebola was very low relative to the Ampligen® serum levels achievable in humans (See November 3, 2014 press release entitled Hemispherx Biopharma and United States Army Medical Research Institute of Infectious Diseases (USAMRIID) Collaborate on Alferon® and Ampligen® Against the Ebola Virus… Initial Ebola Studies of Alferon® and Ampligen® at USAMRIID Show Protective Activity of Both Compounds at Low Concentrationshttp://www.hemispherx.net/content/investor/default.asp?goto=805 ). Together, the three recent reports by Howard University, University of Cagliari, and USAMRIID scientists set the stage for accelerated clinical development of Ampligen® for prevention and treatment of EVD.

Our overall objectives include plans to continue seeking approval for commercialization of Ampligen® in the United States and abroad as well as to widen existing commercial therapeutic indications of Alferon® N Injection® presently approved in the United States and Argentina. In addition, we have formed collaborations with multiple research laboratories around the world to examine Ampligen®, an experimental therapeutic, and Alferon® N, an FDA-approved commercial product as potential preventatives for, and treatments of, Ebola Virus Disease.

About Alferon® N

Alferon® N is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon® N is approved in the U.S. only for the treatment of refractory or recurring external genital warts caused by human papilloma virus in patients 18 years of age, or older. Positive results against Ebola in vitro have been reported to the Company by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). Clinical trial data will be necessary to establish human efficacy of Alferon® N for Ebola virus.

About Ampligen®

Ampligen®, an experimental therapeutic, is a new class of specifically-configured ribonucleic acid (RNA) compounds targeted as potential treatment of diseases with immunologic defects and/or viral causation. Ebola virus specifically inhibits the dsRNA within cells via a sequestration process. Such RNA would otherwise cause a robust antiviral response to be mounted: Ampligen may be able to overcome this deficiency in host response. Positive results against Ebola in vitro have been reported to the Company by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and other research/academic institutions. Clinical trial data will be necessary to establish human efficacy of Ampligen® for Ebola viruses.

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders especially life-threatening viruses. Hemispherx's flagship products include Alferon® N Injection® and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases including cancers. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon® N Injection®), approved for sale in the U.S. and Argentina. The FDA approval of Alferon® N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company's Alferon N Injection® approval in Argentina includes the use of Alferon N Injection® (under the brand name "Naturaferon") for use in any patients who fail, or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. Most newer regimens for creating apparent "cures" in chronic active hepatitis C disease require interferon as a vital component of a successful treatment regimen. The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.

Disclosure Notice

The information in this press release includes certain "forward-looking" statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome in the United States. The production of new Alferon® API inventory will not commence until validation phases are complete. While the facility is approved by FDA under the Biological License Application ("BLA") for Alferon®, this status will need to be reaffirmed upon the completion of the facility's enhancements prior to commercial sale of newly produced inventory product. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the Ampligen® NDA in the United States and other countries. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of the Ampligen® NDA in the United States and other countries.

Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. The final results of these efforts could vary materially from Hemispherx's expectations.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "intends," "plans," and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof. No evidence is suggested that Alferon® N, Alferon® LDO and/or Ampligen will ever be commercially approved for the new potential treatment indications mentioned in this release.

- See more at: http://globenewswire.com/news-release/2014/12/09/689822/10111624/en/Hemispherx-Announces-Data-Showing-Inhibition-of-Ebola-by-Ampligen-R-Enlarged-by-Howard-University-Research.html#sthash.cbim3z1y.dpuf

People with mental health problems are victims of a ‘scam’ therapy that is wasting vast sums of money, a leading psychologist has warned.

They are being misled because the short-term fix offered by Cognitive Behavioural Therapy (CBT) does not have a lasting benefit, says Oliver James.

The most popular of the ‘talking therapies’ CBT aims to help people manage their problems by changing the way they think and behave to become more positive.

It is frequently recommended for people with problems ranging from anxiety and depression to eating disorders.

In the short-term, 40 per cent of those who complete a course of CBT, typically five to 20 sessions of up to an hour, are said to have recovered.

But ‘extensive evidence’ shows that two years on, depressed or anxious people who had CBT were no more likely to have recovered than those who had no treatment, said Mr James.

He said: ‘As a treatment, rafts of studies have shown it to be ineffective in delivering long-term therapeutic benefits to patients with anxiety and depression.

‘While studies show that in the short-term - six to 12 months - patients who have received CBT are more likely to report themselves as ‘recovered’ compared to those who have received no treatment, these results are not sustained in the long-term.

‘CBT is largely ineffective for the majority of patients. It is in essence a form of mental hygiene.

‘However filthy the kitchen floor of your mind, CBT soon covers it with a thin veneer of ‘positive polish’.

Unfortunately, shiny services tend not to last. CBT fails to address the root cause of many people’s problems, which often stem from traumatic experiences during their childhood.

The UK Government has pledged up to £400 million on treatment programmes which mostly use CBT and it is recommended as frontline NHS treatment for many mental health issues.

Mr James, a chartered psychologist, author and broadcaster, delivered his argument to the CBT industry at the Limbus Critical Psychotherapy Conference in Devon this weekend.

WHAT IS CBT?

CBT, or Cognitive Behaviour Therapy, is a talking therapy.

It has been proved to help treat a wide range of emotional and physical health conditions in adults, young people and children.

CBT looks at how a person thinks about a situation and how this affects the way they act.

In turn actions can affect how a person thinks and feels.

The therapist and client work together in changing the client’s behaviours, or their thinking patterns, or both of these.

He and other psychotherapists are calling on the Government and policymakers to refocus funding into alternative talking treatments, such as psychodynamic therapy, which focus on addressing the root cause of people’s cognitive problems.

The NHS has been advised that CBT may be offered to patients with a range of conditions by the National Institute for Health and Clinical Excellence (NICE), the guideline body.

It is free on the NHS after referral by a GP but not available in all areas and there can be long waiting lists.

The cost of private therapy sessions varies, but it is usually £40 - £100 a session.

Many mental health groups welcome the shift in emphasis in recent years away from medication towards personalised therapy.

But Mr James says research shows CBT is no more effective than placebo in treating anxiety or depression

He says proponents have ‘mis-sold’ the treatment to policymakers and the public, who are wasting their time.

"Plenty of people are still dying of diseases which other people do not believe." (Dr. M.N.C. Dukes).CBT and GET for ME: "There is no nonsense so gross that society will not, at some time, make a doctrine of it and defend it with every weapon of communal stupidity."

Robertson Davies

THE NICEGUIDELINES BLOG VERSUS THE NICEGUIDELINES

These are NOT the NICEGuidelines. This is "The NICEGUIDELINES BLOG." What are the differences:

The NICE Guidelines are biased publications based on the GOBSART (Good Old Boys Sitting Around a Table) approach.

This Blog however is not only evidence based but also uses critical reading to judge papers and articles. I also use common sense and listen to others. And finally I read both psychiatric and medical evidence and opinions from around the world to come to a conclusion.

I’m not sponsored by anybody or paid by whatever company as seems to be the norm with many psycho people who publish the same article almost on a weekly base.

So if you value an opinion, formed as a result of participating in many ME activities, for example being bed bound for years, you have come to the right BLOG. All these activities have allowed me to form an opinion as a Doctor and as a Patient. And that is important as the voice of the latter is discarded by many including NICE.

If you don’t read this blog, you will miss out on “accredited” medical education. If you do read it, you may actually become a doctor who doesn’t stop thinking or forgets to ask critical questions. Many good things, including satisfied patients are at your command.

So, if you arrived here for the straightforward GOBSART approach, I will disappoint you. If you are interested in forming your own opinion about ME, and other interesting things, read on!

About Dr. Speedy.

I am a Family Physician or GP as it is called in Australia or the UK. I am also an ME patient unfortunately. Bedbound that is. So at the moment I’m in private practice so to speak. I’ve got only one patient, ME, or is it me?

I graduated as a doctor a long time ago, and I am the founder and editor of The NICEGUIDELINES BLOG, an internet based ME BLOG that is devoted to critical reading and cheering you or ME up.

I have the following conflict of interest: I would like to get better and see that the wasting of public money on CBT (talk therapy for a neurological disease, really helpful) and other silly therapies for ME stops, and will be used in better ways.

My goal has always been to help, and if possible, cure patients. With this disease you will soon find out that many psychiatrists and psychologists are only in it to make money and get their name in the spotlight. And what happens to and with the patients is irrelevant.

I stand to benefit both mentally, physically and also financially if this silliness would stop, and I would get my health back, and I can go back to work and have a normal life again. Please evaluate my postings with this in mind! And remember, there are also (lots of) psychiatrists and psychologists who haven’t switched their brain off.